Today's announcement did not compare 12 week data for the dose-escalation and expansion arms, so here it is:
Dose escalation (400/800/1200 mg) - 14 patients enrolled
Stable disease - 8/14 = 57%
Partial response - Nil
PSA down >50% - 5/14 = 36%
Pain down >30% - 5/14 = 36%
1200 mg group - 12 patients, one withdrew for personal reasons, 8 had measurable tumours
Stable disease - 6/8 = 75%
Partial response - 2/8 = 25%
PSA down >50% - 6/11 = 55%
Pain down <30% - 5/11 = 45%
A pedant might quibble about the number of patients to be evaluated, but the trend is clear.
These data show that 1200 mg performed better than the first group; and that either group would be better than palliative radiation alone, based on historical results. As the Phase 2/3 trial will include additional doses of Veyonda monotherapy, I am confident that we have a drug that will achieve FDA approval.
Add to My Watchlist
What is My Watchlist?
